Lumbreras-Lacarra Blanca, Ramos-Rincón José Manuel, Hernández-Aguado Ildefonso
Department of Clinic Analysis, General University Hospital of Alicante, Alicante, Spain.
Clin Chem. 2004 Mar;50(3):530-6. doi: 10.1373/clinchem.2003.019786. Epub 2004 Jan 12.
The application of epidemiologic principles to clinical diagnosis has been less developed than in other clinical areas. Knowledge of the main flaws affecting diagnostic laboratory test research is the first step for improving its quality. We assessed the methodologic aspects of articles on laboratory tests.
We included articles that estimated indexes of diagnostic accuracy (sensitivity and specificity) and were published in Clinical Chemistry or Clinical Chemistry and Laboratory Medicine in 1996, 2001, and 2002. Clinical Chemistry has paid special attention to this field of research since 1996 by publishing recommendations, checklists, and reviews. Articles were identified through electronic searches in Medline. The strategy combined the Mesh term "sensitivity and specificity" (exploded) with the text words "specificity", "false negative", and "accuracy". We examined adherence to seven methodologic criteria used in the study by Reid et al. (JAMA1995;274:645-51) of papers published in general medical journals. Three observers evaluated each article independently.
Seventy-nine articles fulfilled the inclusion criteria. The percentage of studies that satisfied each criterion improved from 1996 to 2002. Substantial improvement was observed in reporting of the statistical uncertainty of indices of diagnostic accuracy, in criteria based on clinical information from the study population (spectrum composition), and in avoidance of workup bias. Analytical reproducibility was reported frequently (68%), whereas information about indeterminate results was rarely provided. The mean number of methodologic criteria satisfied showed a statistically significant increase over the 3 years in Clinical Chemistry but not in Clinical Chemistry and Laboratory Medicine.
The methodologic quality of the articles on diagnostic test research published in Clinical Chemistry and Clinical Chemistry and Laboratory Medicine is comparable to the quality observed in the best general medical journals. The methodologic aspects that most need improvement are those linked to the clinical information of the populations studied. Editorial actions aimed to increase the quality of reporting of diagnostic studies could have a relevant positive effect, as shown by the improvement observed in Clinical Chemistry.
流行病学原理在临床诊断中的应用相比其他临床领域发展较缓。了解影响诊断性实验室检测研究的主要缺陷是提高其质量的第一步。我们评估了关于实验室检测的文章的方法学方面。
我们纳入了估计诊断准确性指标（敏感性和特异性）且于1996年、2001年和2002年发表在《临床化学》或《临床化学与检验医学》上的文章。自1996年以来，《临床化学》通过发表建议、清单和综述对该研究领域给予了特别关注。通过在Medline中进行电子检索来识别文章。该策略将主题词“敏感性和特异性”（展开）与文本词“特异性”、“假阴性”和“准确性”相结合。我们检查了发表在普通医学期刊上的论文对Reid等人（《美国医学会杂志》1995年；274：645 - 51）研究中使用的七个方法学标准的遵循情况。三位观察者独立评估每篇文章。
79篇文章符合纳入标准。从1996年到2002年，满足每个标准的研究百分比有所提高。在诊断准确性指标的统计不确定性报告、基于研究人群临床信息的标准（谱组成）以及避免检查偏倚方面观察到了显著改善。分析可重复性报告频繁（68%），而关于不确定结果的信息很少提供。满足的方法学标准的平均数量在《临床化学》中3年里有统计学显著增加，但在《临床化学与检验医学》中没有。
发表在《临床化学》和《临床化学与检验医学》上的诊断检测研究文章的方法学质量与在最佳普通医学期刊中观察到的质量相当。最需要改进的方法学方面是那些与所研究人群的临床信息相关的方面。如《临床化学》中观察到的改进所示，旨在提高诊断研究报告质量的编辑行动可能会产生相关的积极影响。
